Regardless, let’s look at stupidity in its highest form.
Medical device companies have upped their game in product security and regulatory compliance, but they might not be ready for a catastrophic event.
Having trained biomedical equipment technicians in developing regions can help, but lack of funding is perpetuating a dire situation.
A Q&A on how device companies can respond to supply chain risks and regulations.
Failure to provide records during an inspection will undoubtedly lead to a warning letter.
Achieving success in India involves patience and a firm grasp on the culture and regulatory environment.
In order to keep innovation and manufacturing in the United States, device companies need federal and local support.
You need a management representative with oversight over medical device quality.
A company statement aims to set the record straight.
Perhaps the organizational soul searching should begin after receiving one Form 483.